Compliance objective

Food and Drug Administration

Quality Assurance

Good Manufacturing Practices

GMP Care Consult suggests achieving compliance through:

• Auditing
• Advising
• Training and coaching
• Conception and implementation of measurement systems

By acting on

• The people
• Skills, training and qualification
• The different systems (Quality, Traceability, Preventive Maintenance, Production, Logistics)

On the basis of specific tools

• Quality Plan
• SOPs
• Batch Records
• Annual Product Review
• CAPA
• Training Master Plan
• Change Control
• Internal Audit

Examples

• Preparing FDA inspections: introduction to the working methods of Anglo-American audit firms, war-room management, behavioral analysis, ‘Do-Don't', conversation tables in English, simulation...
• Aseptic behavior: theoretical and practical training in work under aseptic conditions, acquisition of adequate behavior
• GMP compliant documentary practices: creation of a documentation and traceability system
• Train the trainer: trainers perfect the art of training
• Interns take responsibility for your training plan